Quality Assurance & Regulatory Affairs Officer

Qualifications:

• Bachelor’s degree in Pharmacy or Apothecary.

• Strong interest in Quality Assurance, Regulatory Affairs, certification processes, or consulting within the healthcare, pharmaceutical, medical device, cosmetic, or related industries.

• Basic understanding of quality management systems and regulatory standards such as BPOM, ISO, Halal, GMP, HACCP is an advantage.

• Strong willingness to learn and actively contribute to regulatory compliance and certification processes.

• Good interpersonal and communication skills.

• Detail-oriented, well-organized, and able to manage multiple tasks simultaneously.

• Proficient in Bahasa Indonesia and English, both written and spoken (mandatory).
  

Job Description:

• Prepare, review, and manage regulatory and certification documents in accordance with applicable regulations and standards.

• Coordinate and support certification, audit, and mock audit activities, including preparation, execution, and CAPA (Corrective and Preventive Action) follow-up.

• Compile, maintain, and update regulatory dossiers, technical documents, and supporting evidence.

• Actively coordinate and communicate with clients, certification bodies, and regulatory authorities to ensure timely submission and compliance.

• Monitor updates on regulatory requirements and standards, and support implementation within ongoing projects.

• Provide basic regulatory and certification guidance to clients under the supervision of senior team members.

• Maintain proper documentation control and filing systems for regulatory and certification records.

• Support continuous improvement initiatives related to regulatory compliance and quality systems.